Team Lead Pharma Registration Germany, Life Science (all genders)

Posted 23 Jun 2022

Darmstadt, Hessen - Germany

Req Id 240495

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role: As Head of Pharma Registrations Germany in LS Regulatory organization you will be responsible to plan and handle regulatory activities for both new and existing products such as active pharmaceutical ingredients, excipients, process materials for pharmaceutical production (e.g., cell culture media, enzymes) used in formulation and/or up/down stream (biopharma process). You run the preparation of technical files for registrations according to authority requirements in the country / region of submission (DMF, CEP, ASMF). You work in a global setup to ensure site registrations worldwide and notification of products at manufacturing sites that produce LS products. This includes compliance to import and export requirements and management of related authority fees (e.g., GDUFA registration fees). As member of an international and interdisciplinary team, you will also be responsible to design and implement policy and workflows in collaboration with the local units of the sites, local agents and subsidiaries. You are responsible to follow-up and inform about new and upcoming regulations and to initiate related activities for implementation relevant to the intended use of substances for pharmaceutical use manufactured at the LS sites in Germany. You will be the regulatory liaison partner with Commercial, Manufacturing sites, Operations, Distribution, Trade Compliance, QA, QC and Regional Regulatory units. You will guide peers and middle management regarding regulatory issues and challenges within his/her subject area. In addition, you will provide regulatory support and guidance to marketing and commercials via seminars / trainings / events. You ensure participation and contribution to relevant industry association working groups related to APIs and excipients (e.g., IPEC, APIC, etc.) and/or governmental organizations.

 

Who you are:

  • Masters or PhD degree (e.g., pharmacy, chemistry, biology)
  • Leadership and project management skills, team spirit and strong communication skills
  • Comprehensive expertise in regulatory affairs of APIs/excipients (ASMF/DMF regulations, China excipient registrations)
  • Experience with regulatory and quality requirements for pharmaceutical starting materials, well versed with relevant GMP requirements for APIs and excipients,
  • Prior experience with electronic regulatory data management system like Veeva and regulatory certification will be added advantage
  • Proficient in English and German language

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

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